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On July 10, 2012, in response to requirements in legislation that passed Congress with broad bipartisan support, the Food and Drug Administration published a proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI, except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device (e.g., devices sold over-the-counter and low risk devices

On February 6, 2012, the FDA adopted as a final rule, without change, the interim final rule from December 28, 2007 that permitted FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile